drugset / Trial / NCT04226066
Safety, Tolerability and Pharmacokinetics Characteristics of Recombinant Oncolytic Vaccinia Virus Injection T601 as a Single Drug or in Combination With Oral Flucytosine (5-FC), in Patients With Advanced Malignant Solid Tumors
NaSequentialOpen-labelTreatment
Summary
This open, dose-escalation and extended PhI/IIa clinical trial aims to evaluate the safety, tolerability of T601 as a single-agent as well as combined with prodrug 5-FC to treat patients with advanced malignant solid tumors and to explore the pharmacokinetic characteristics of T601, 5-FC, 5-FU, FBAL, which includes PhI study of dose-escalation study and Ph IIa study of extending study.
Timeline
- Start
- 2019-11-20
- Primary completion
- 2021-05-31
- Completion
- 2022-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flucytosine | Small molecule | — | Oral |
| Subject | T601 | Unknown | 1e+07 unknown | — |
| Subject | T601 | Unknown | 3e+07 unknown | — |
| Subject | T601 | Unknown | 1e+08 unknown | — |
| Subject | T601 | Unknown | 3e+08 unknown | — |
| Subject | T601 | Unknown | 1e+09 unknown | — |